Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association
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Clin. Gastroenterol. Hepatol. · Jun 2014
Randomized Controlled TrialEffect of ramosetron on stool consistency in male patients with irritable bowel syndrome with diarrhea.
Ramosetron, a serotonin (5-hydroxytryptamine)-3 receptor antagonist with high selectivity, reduced stress-induced diarrhea and defecation caused by corticotropin-releasing hormone in rats. However, there have been no clinical trials of its effect in patients with diarrhea and irritable bowel syndrome (IBS-D). We performed a randomized, double-blind, placebo-controlled trial to determine whether ramosetron reduces diarrhea in these patients. ⋯ Ramosetron (5 μg oral, once daily for 12 weeks) improved stool consistency in male patients with IBS-D, compared with placebo. These study results, along with the pharmacologic profile of ramosetron, indicate that increased stool consistency is the best end point for studies of ramosetron in patients with IBS-D. Clinicaltrials.gov No, NCT01225237.